PMTA Checklist

July 30, 2024

"Is there a PMTA checklist?" - The premarket tobacco product application process is by no means simply a checklist exercise but I get this question quite often. Checklists are intuitive and show demonstrable progress so I thought I would provide an example here. It’s possible to go 3 levels deeper for each of these sections. This is simply a fun example. Please do your own research as well or reach out to me at jon@diceregulatory.com. I have plenty of job aids, reviewer guides and submission tools to help understand CTP process and develop strategy. I share some of this information on my website www.diceregulatory.com.

1. Administrative Requirements

FDA Forms:

☐ FDA Form 4057 (New PMTA)

☐ FDA Form 4057b (Product Grouping Spreadsheet)

☐ FDA Form 4057a (Amendments or General Correspondence)

Application Format:

☐ Ensure compliance with format requirements as per 21 CFR 1114.7(b) for standard PMTA.

☐ Table of Contents provided.

Right of Reference:

☐ Include right of reference for applications referencing Tobacco Product Master Files (TPMFs).

Translations:

☐ Certified English translations of any non-English documents.

☐ Certification statement by an authorized representative confirming translations are complete and accurate.

☐ Statement of qualifications of the translator.

2. Product Description and Labeling

Detailed description of the tobacco product, including:

☐ Product name

☐ Product category and subcategory

☐ Product components and ingredients

☐ Manufacturing processes

☐ Labeling and marketing information:

☐ Product labels

☐ Marketing materials and advertisements

☐ Packaging specifications

3. Environmental Assessment (EA)

Product-specific Environmental Assessment, including:

☐ Impact of product use

☐ Impact of product disposal

☐ Any mitigation measures for potential environmental impacts

4. Health Risk Assessment

Nonclinical studies:

☐ Toxicology data

☐ In vitro and in vivo studies

☐ Genotoxicity studies

Clinical studies:

☐ Human clinical trials

☐ Pharmacokinetics and pharmacodynamics data

☐ Abuse liability studies

Literature Review:

☐ Comprehensive review of existing scientific literature related to the product and its constituents.

5. Behavioral and Perception Studies

Studies on consumer perception and use patterns:

☐ Surveys and focus groups

☐ Behavioral studies on initiation, cessation, and dual use

☐ Marketing studies

6. Product Chemistry and Stability

Detailed product chemistry:

☐ Chemical composition

☐ Nicotine content and delivery

☐ Harmful and potentially harmful constituents (HPHCs)

☐ Stability testing data:

☐ Shelf-life studies

☐ Storage conditions and stability over time

7. Manufacturing Information

Comprehensive manufacturing process description:

☐ Facilities and equipment used

☐ Quality control measures

☐ Batch production records

Good Manufacturing Practices (GMP) compliance:

☐ GMP certification or compliance statement

☐ Quality assurance protocols

☐ Tobacco Product Manufacturing Practice (TPMP) in development

8. Postmarket Surveillance and Reporting

Plan for postmarket surveillance:

☐ Methods for monitoring adverse events

☐ Procedures for reporting to FDA

☐ Consumer complaint management

Risk management plan:

☐ Strategies for mitigating identified risks

☐ Plans for addressing emerging risks

9. Executive Summary

Comprehensive executive summary of the PMTA, including:

☐ Overview of the product and its intended use

☐ Summary of key findings from health risk assessments, behavioral studies, and manufacturing information, youth-use mitigation plans

☐ Justification for marketing authorization

Acceptance Criteria (Based on CTP’s Key to Acceptance Review V1 - March 24, 2017)

Completeness and Organization:

☐ Ensure all required sections and documents are included.

☐ Clearly labeled and organized application with a table of contents.

Regulatory Compliance:

☐ Compliance with format and content requirements as per 21 CFR 1114.

☐ Inclusion of all required FDA forms.

Scientific and Technical Data:

☐ Sufficient scientific and technical data to support safety and efficacy.

☐ Comprehensive health risk assessments and environmental assessments.

Right of Reference and Intellectual Property:

☐ Appropriate rights of reference for any referenced TPMFs or third-party data.

Translation and Certification:

☐ Complete and accurate translations with proper certification.

Labeling and Marketing Consistency:

☐ Consistency between product labeling, marketing materials, and the application content.